Darzalex
Darzalex ingredients
| Active ingredient | Strength |
|---|---|
| Daratumumab | 100 mg/5mL |
What Darzalex is used for
The FDA lists the approved uses on the official label (below). In the EU, daratumumab is approved as Darzalex for:
Multiple Myeloma Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have…
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Darzalex
- Generic name
- Daratumumab
- Made by
- Janssen Biotech, Inc.
- Forms
- Injection, Solution, Concentrate
- Given
- Intravenous
- Drug class
- CD38-directed Cytolytic Antibody
- FDA approval
- Biologic licence (BLA) BLA761036
- On the US market since
- 2015
Official information
- MedlinePlus drug information (search for Daratumumab)
In India
- Daratumumab: 2 brands in India
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Darzalex?
Darzalex (Daratumumab) is a cancer medicine made by Janssen Biotech, Inc., approved by the US FDA.
What are the ingredients of Darzalex?
Darzalex contains Daratumumab (100 mg/5mL).
Is Darzalex approved in Europe?
The same active substance is approved in the EU as Darzalex.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA